PLGA
PLGA polymer is a random copolymer, amorphous, widely used in surgical sutures, anti-adhesive films, tissue engineering scaffolds, and absorbable microspheres, such as medicine-loaded slow-release microspheres.
Compared with PLLA, the polymer degradation time can be controlled by the GA content, and the material is soft and flexible.
Different types of PLGA can be prepared with various monomer ratios to meet diverse biomedical manufacturing needs, including commonly specified ratios like PLGA 50:50, PLGA 75:25, and PLGA 85:15. For example, PLGA 75:25 means that the polymer consists of 75% L-LA and 25% GA. The degradation time of PLGA is varied by the monomer ratio; the higher the GA content, the easier it is to degrade.
Product Index（PLGA 50：50）:
| Item | Unit | Standard Values | Reference Standard | Method | Result |
| Appearance | / | White to off white granules | / | Visual Inspection | conforms |
| Intrinsic Viscosity [η] | dL/g | / | YY/T 0661-2017 |
Refer to ASTM D 2857 30℃ in Chloroform |
0.40 |
| Moisture | % | ≤0.3 |
GB/T 37642-2019 |
KFT | 0.13 |
|
L-LA Monomer residue |
% | ≤2 | YY/T 0661-2017 | GC | 0.17 |
|
GA Monomer residue |
% | ≤0.5 | YY/T 0661-2017 | GC | 0.06 |
| THF solvent residue | ppm | ≤720 | YY/T 0661-2017 | GC | conforms |
| Total solvent residue | ppm | ≤1000 | YY/T 0661-2017 | GC | conforms |
| Heavy metal residue(Pb) | μg/g | ≤10 | YY/T 0661-2017 | 0841 Heavy metal detection method in Chinese Pharmacopoeia | conforms |
| Sn Residue | μg/g | ≤150 | YY/T 0661-2017 | ICP | conforms |
| Molar ratio | % | ±5 | YY/T 0661-2017 |
HNMR（L-LA：GA） |
48.4:51.6 |
*Produced in GMP workshop, each batch will provide the corresponding COA report.
| Model No. | Intrinsic Viscosity [η] (dL/g) | Test Conditions |
| PLGA8523 | 2.00-2.50 | TCM，25℃ |
| PLGA8531 | 2.70-3.50 | TCM，25℃ |
| PLGA7510 | 0.70-1.20 | TCM，25℃ |
| PLGA7520 | 1.80-2.40 | TCM，25℃ |
| PLGA7530 | 2.50-3.50 | TCM，25℃ |
| PLGA5003 | 0.20-0.40 | TCM，25℃ |
| PLGA5010 | 0.80-1.20 | TCM，25℃ |
| PLGA5014 | 1.20-1.60 | TCM，25℃ |
